Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)

Not Applicable

Completed

• Conditions: Full Thickness Macular Hole
• Interventions: Behavioral: Face down posture

• Registration Number: NCT01020760
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-26
• Primary Completion: 2010-08
• Study Completion: 2010-10
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-25
• Last Update Posted: 2012-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients having surgery for idiopathic full thickness macular hole
2. Able and willing to posture face-down for 10 days postoperatively
3. Agree to participate in the trial and able to give informed consent

Exclusion Criteria

1. History of visual loss suggesting a duration of macular hole greater than 12 months
2. Patients unable or unwilling to posture face-down for 10 days postoperatively
3. History of trauma that may have been causative
4. Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
5. Previous vitrectomy surgery
6. Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face down posture	Face down posture	Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to posture in the face down or prone position for 50 minutes per hour for seven days.

Primary Outcome Measures

Name	Time	Method
estimate variance and effect size order to inform power calculations for further studies.	one year

Secondary Outcome Measures

Name	Time	Method
visual acuity and complications	one year
estimate recruitment rate and establish protocol/procedure	one year

Trial Locations

Locations (1)

Gartnavel General Hospital; 🇬🇧 Glasgow, United Kingdom